Guoping Zhuo

Experience

• 

  Japan Medical Supply Singapore Pte Ltd

  Sept 2011 - Nov 2014

  Product Development Engineer

  -In-charge of product development in Arterial Venous Fistula products-Project management Design change request (both internal and external customers); coordinate with relevant stakeholders (Production, Quality Assurance, Procurement, Regulatory Quality Management System, Planner , Sales & Marketing) for design review; and finally design transfer to process owner-Projects nature (Material qualification, Product Design improvement, Cost down, Process improvement)-Carry out qualification work from DOE phase to First Article and ending with Stability Run phase-Handle documentation (Design History Files; Engineering Change Order) including regulatory documents (Technical File for TUV Audit; 510K for FDA Audit) Show less

• 

  UL Solutions

  Nov 2014 - now

  1) Project Handling of Product Safety Standards; including report compilation and conducting tests- Medical electrical equipment (IEC 60601 series)- Measurement and Laboratory use including IVD (IEC61010 series)2) Project reviewer supporting regional colleagues; including technical auditor role3) Coordinate biocompatibilty test requests to support manufacturer in their regulatory submission4) Handling of inquiries relevant to Service Lines and supporting AANZ Sales on technical knowledge5) Responsible for maintenance of lab accreditation scope, through various audit schemes6) Support local and regional training on Standards knowledge7) Engage clients on construction/document issues prior to certification; and CE mark compliance through explanation of European Directives/Regulations and respective Harmonized Standards8) In charge of engineers to deliver revenue fulfillment9) Subject Matter Expert for System tools; providing support to APAC team Show less 1) Project Handling/Coordination and fulfillment for Product Safety Standards:- Medical electrical equipment (ANSI/AAMI ES 60601-1; IEC 60601-1; IEC 60601-1-6; IEC 60601-1-11)- Measurement and Laboratory use including IVD (UL61010-1; IEC 61010-1; IEC 61010-2-010; IEC 61010-2-081; IEC 61010-2-101; IEC 61010-2-030)2) Hybrid role involving report compilation and testing according to involved product safety standards through Witness and In-house testing approaches3) Handling of inquiries relevant to Service Lines and supporting Sales on technical knowledge4) Responsible for scope expansion of current product safety lab for Medical standard5) Support local and regional training on Standards knowledge6) Advising clients on construction/document issues prior to certification; and CE mark compliance through explanation of European DIrectives/Harmonized Standards Show less Main roles:1) Project handler for IEC 61010/UL/EN 61010 (Safety requirements for Electrical equipment for measurement, control and laboratory use) in ASEAN region; involving witnessing tests with UL DAP (Data Acceptance Program) clients2) UL representative in SMF (Singapore Manufacturing Federation)Medical Technology Industry Group (MTIG)3) Work with Sales manager in providing technical and engineering support for UL - Life and Health Product Safety services in ASEAN region4) Promoting other UL - Life and Health services: - Solutions (MRAS - Medical Regulatory Advisory Services)- MDT (Biocompatibility Evaluation to ISO 10993)- HFE (Human Factors Engineering)- Eduneering- Notified Body Audit5) Signatory for UL/IEC 61010 for local UL laboratory in SAC-SINGLAS program6) Signatory for IEC 61010 for local UL CBTL in CB Scheme Show less

  • Senior Project Engineer

    Apr 2023 - now

  • Project Engineer

    Jan 2020 - Apr 2023

  • Engineer Project Associate

    Apr 2017 - Jan 2020

  • Engineer

    Nov 2014 - Apr 2017